Events

Recall of ENDOPATH XCEL" with OPTIVIEW" Technology trocar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56939
  • Event Risk Class
    Class 2
  • Event Number
    Z-0336-2011
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95076
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laparoscope, general& plastic surgery - Product Code DRC
  • Reason
    This recall has been initiated because ethicon endo-surgery is aware of an increase in reports of leaking in the endopath¿ xcel" with optiview" technology trocar, which potentially can lead to loss of pneumoperitoneum during a surgical procedure. pneumoperitoneum leaks may lead to conversion from laparoscopic to open surgery.
  • Action
    Ethicon Endo-Surgery sent an URGENT: DEVICE RECALL EVENT 2244 letter, dated October 8, 2010. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to stop using the product, examine all inventory to determine if they had the affected product on hand, and remove the affected products from inventory. Ethicon Endo-Surgery requested that each customer complete the Business Reply Form and fax it back to Stericycle at (877) 272-6141 with in 3 business days and also return any affected product to Stericycle. For question regarding this recall call (877) 598-5706 and reference 2244.

Device

ENDOPATH XCEL" with OPTIVIEW" Technology trocar
  • Model / Serial
    Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U, G4RZ7L, G4T33Y & G4T58C. Product Code #: 03B11LPH- Lot #'s: G4RX8G, G4RZ3X & G4T03X. Product Code #: 03B11LT- Lot #'s: G4RH57, G4RH49, G4RJ9H, G4RK2U, G4RK90, G4RL5P, G4RM16, G4RM1F, G4RM7E,G4RN1E, G4RP3L, G4RT0T, G4RT9D, G4RV4M, G4RV4D, G4RW9Z, G4RX5R, G4RY23, G4RY7P, G4RZ6G, G4T093, G4T167, G4T22M, G4T27A, G4T27W, G4TC7V, G4TD1U, G4TE1P, G4TF0N, G4TF3J, G4TH07, G4TG6D, G4TH5L, G4TJ44, G4TK1J, G4TK6E, G4TL3A, G4TL95, G4TM49, G4TM88, G4TN2H, G4TN88, G4TP1R, G4TP4X, G4TP89,G4TR4X,  G4TT3K, G4TT97, G4TU8J, G4TV4W, G4TW1C, G4TX0C & G4TX8Z. Product Code #: 03B11LTH-Lot #'s: G4RW20, G4T03Y, G4T26Y, G4T49F, G4T73A, G4TX0R & G4TX9D. Product Code # 03B12LP-Lot #'s: G4RV5F, G4RY26, G4T27X, G4T55H & G4T75Y. Product Code #: 03B12LPH-Lot #'s: G4RW5T, G4RZ3Y, G4T03Z, G4T32C & G4T49G. Product Code #: 03B12LT-Lot #'s: F4PX6F, F4PZ4D, F4PZ22, F4PY9K, F4PY9E, F4PZ6F, F4PZ9Z, F4R01X, F4R039, F4R00M, F4R09W, F4R10Z, F4R15N, F4R18K, F4R18E, F4R234, F4R255, F4R278, F4R256, F4R35D, F4R34N, F4R34L, F4R369, F4R393, F4R40J, F4R44A, F4R458, G4R601, G4R71Y, G4R71Z, G4R80H, G4R77Z, G4R77Y, G4R860, G4R87V, G4R920, G4R915, G4R962, G4R97Z,  G4R84L, G4RA7D, G4RA8N, G4RC45, G4RC79, G4RC8D, G4RC98, G4RD2A, G4RC8E, G4RD24, G4RD4V, G4RE84, G4RG18, G4RG3T, G4RG83, G4RF0A, G4RH0C, G4RG31, G4RG32, G4RF8C, G4RJ08, G4RJ92, G4RJ9E, G4RK6L, G4RL02, G4RL1L, G4RL2E,G4RL8P, G4RL8Y, G4RM31, G4RM49, G4RN06, G4RN27, G4RN30, G4RN2K, G4RN5D, G4RN8F, G4RN7Z, G4RP1K, G4RR2N, G4RR3K, G4RT28, G4RT09, G4RT3G, G4RT3J,G4RU8H, G4RV1F, G4RV1G, G4RV89, G4RV8J, G4RW55, G4RW54, G4RX59, G4RZ15, G4RY7W, G4RY8V, G4RY8W, G4RZ29, G4RZ6W, G4RZ6V, G4RZ6H, G4RZ6U, G4T01U, G4T04J, G4T04H, G4T14X, G4T23R, G4T296, G4T34K, G4T36A, G4T34P, G4T41E, G4T44W, G4T46C, G4T45N, G4T50W, G4T529, G4T63Z, G4T66H, G4T64N, G4T66J, G4T750, G4T70Y, G4T711,  G4T73J, G4T78T, G4T81R, G4T78U, G4T83Y, G4T93A, G4T87T, G4T95J, G4T90T, G4T89V, G4T94W, G4T941, G4T940, G4T976, G4TA1E, G4TA5W, G4TA7D, G4TA5X, G4TA9H,G4TA96, G4TC3Y, G4TC4Y, G4TC4X, G4TC80, G4TD3W, G4TD3G, G4TF02, G4TD8Z, G4TD9Z, G4TF8Z, G4TG0W, G4TG31, G4TG4H, G4TG6X, G4TH16, G4TH5M, G4TH79, G4TJ2A, G4TJ6U, G4TJ5W, G4TJ8Y, G4TJ9W, G4TK2F, G4TK86, G4TK9H, G4TL5Z, G4TL7R, G4TL9N,  G4TM5T, G4TM3H, G4TM87, G4TP14, G4TR1F, G4TP7K, G4TR54, G4TR3A, G4TR7H, G4TR9M, G4TT0G, G4TT20, G4TT43, G4TT7R, G4TU1D, G4TU3J, G4TV22, G4TU89, G4TW0N, G4TV5V, G4TW3V, G4TW5U, G4TX16, G4TX2D, G4TX8R, G4TX7E & G4TY19. Product Code #: 03B12LTH- Lot #'s: G4RW31, G4RW2R, G4RZ48, G4T00F, G4T27C, G4T448, G4T56N, G4T549, G4T59L, G4T65G, G4T709, G4TE35, G4TF2E, G4TG03, G4TG73, G4TH21, G4TM00,  G4TT3F, G4TU3P &G4TX0T.; Product Code #: 03B12SRT- Lot #'s: G4RW52, G4RZ25, G4T05J, G4T465 & G4T76T. Product Code #: 04B12XT-Lot #'s: G4RU2U, G4RW8N, G4RV59, G4RW97, G4T19T, G4T79U, G4TA2A, G4TA7K, G4TD2C, G4TF0R, G4TJ1L, G4TM3X, G4TN8E, G4TR00, G4TT2W, G4TW4E, G4TW55 & G4TY7G. Product Code #'s: 03CB11LT-Lot #'s: G4RH8R, G4RK9Z, G4RL5R, G4RM8H, G4RN6Z, G4RT08, G4RV2F, G4RY0X, G4RZ5N, G4T12D, G4T20J, G4T31F, G4T444, G4T50E, G4TL5Y, G4TL8F, G4TU70 & G4TX6J. Product Code #: 03CB12LT-Lot Code #'s: F4R421, G4R93M, G4R989, G4RA4E, G4RA7Z, G4RA8M, G4RC4N, G4RD94, G4RG1F, G4RG4X, G4RG91, G4RH7X, G4RJ9A, G4RN3R, G4RR4T, G4RT8H, G4RU3C, G4RU6V, G4RV2U, G4RW9J, G4RY1R, G4RY6L, G4RZ68, G4T092, G4T14D, G4T229, G4T243, G4T26W, G4T31T, G4T32W, G4T37M, G4T37N, G4T410, G4T449, G4T45Z, G4T47R, G4T48G, G4T551, G4T71V, G4T74Z, G4T81K, G4T83U, G4T894, G4T92T, G4T98R, G4TA4Z, G4TA9X, G4TC2L, G4TC6L, G4TD1E, G4TD68, G4TE07, G4TE9W, G4TF2M, G4TG16, G4TG61, G4TG8P, G4TH58, G4TJ2G, G4TJ99, G4TK3H, G4TK1H, G4TL76, G4TM3D, G4TM5W, G4TN2E, G4TN81, G4TP0V, G4TP9D, G4TR4W, G4TR77, G4TU0L, G4TU86, G4TV4F, G4TV9F, G4TW9U & G4TX7P. Product Code #: 02D11LT- Lot Code #'s: G4RR2U, G4RR34, G4RT5N, G4RT47, G4RT53, G4RU05, G4RX11, G4RX7V, G4RZ28, G4RZ4M, G4T06C, G4T09H, G4T171, G4T18U, G4T28K, G4T38Y, G4T46L, G4T51N, G4T55T, G4T590, G4T685, G4T77N, G4T98T, G4TA2X, G4TA8U, G4TC16, G4TC5A, G4TC98, G4TD6X, G4TE68, G4TF7D, G4TF9Z, G4TG33, G4TH1A, G4TH45, G4TJ4N, G4TK2N,G4TL1T, G4TL99, G4TM89, G4TN9M, G4TP3D, G4TR6J, G4TV2G, G4TW3Y & G4TX4Y. Product Code #: 02D12LT-Lot Code #'s: G4RM9L, G4RN11, G4RP5H, G4RP69, G4RP6Y, G4RP9Y, G4RR1Z, G4RR2C, G4RR84, G4RR78, G4RU23, G4RV9U, G4RW0P, G4RX2X, G4RY40, G4RY4U, G4RZ7M, G4T07A, G4T11T, G4T15Z, G4T28W, G4T301, G4T32A, G4T364, G4T401, G4T46Y, G4T522, G4T57U, G4T691, G4T733, G4T81X, G4TA8V, G4TC26, G4TC5D, G4TD3H, G4TD4X, G4TD4H, G4TF1K, G4TF8N, G4TG0X, G4TG4C, G4TH27, G4TJ4U, G4TJ6J, G4TJ8W, G4TK50, G4TK32, G4TK8N, G4TR20, G4TR7T, G4TT7T, G4TT7U, G4TU13, G4TU6N,G4TV2Z,  G4TW85 & G4TY0C. Product Code #: 03D12XT-Lot Code #'s: G4RW15, G4RY5J, G4T204, G4T76K, G4TG5C, G4TM47, G4TR7U & G4TV5Y. Product Code #: 03H12LP-Lot Code #'s: F4R042, F4R041, F4R089, F4R097, F4R10H, F4R11U, F4R130, F4R16U, F4R21A, F4R23E, F4R24D, F4R265, F4R25J, F4R33T, F4R38J, F4R36A, F4R408, F4R41Y, G4R74D, G4R77D, G4R83C, G4R95U, G4RA71, G4RC1D, G4RC6L, G4RD09, G4RE99, G4RH13, G4RJ2C, G4RK7E, G4RL15, G4RL3E, G4RP31, G4RP32, G4RP33, G4RM9W, G4RN6G, G4RN9F, G4RR9U, G4RT87, G4RV03, G4RV0R, G4RV1D, G4RW64, G4RX45, G4RY5Y, G4RZ4U, G4T00H, G4T08G, G4T127, G4T19V, G4T19W, G4T29C, G4T37L, G4T40E, G4T50C, G4T49H, G4T52R, G4T52P, G4T70D, G4T65L, G4T749, G4T73F, G4T808, G4T76J, G4T83T,  G4T83A, G4T95M, G4T99R, G4TA1Y, G4TA9R, G4TC2M, G4TD1A, G4TD1H, G4TD2N, G4TF29, G4TF6J, G4TF7C, G4TG97, G4TJ04, G4TJ3J, G4TJ5R, G4TK0T, G4TL0M, G4TL4H, G4TL81, G4TM3J, G4TN10, G4TP2P, G4TR12, G4TR24, G4TR69, G4TT9D, G4TU2D,G4TV5H, G4TV3F, G4TW79, G4TX6F & G4TY05. Product Code #: 03K11LT-Lot Code #'s: G4RX8T, G4RX1V, G4T046, G4T24D & G4TV8K. Product Code #: 03K12LT- Lot Code #'s: G4RW4G, G4RZ49, G4T021, G4T047, G4T24E, G4T69Z, G4T726, G4T823, G4TE0Z, G4TF41, G4TG39, G4TG8J, G4TT2V, G4TV9N, G4TW76 & G4TX7R. Product Code #: 03NSB12LT-Lot Code #'s: G4T43Z, G4T55F, G4T66A, G4T795, G4T853, G4T97F, G4TC0X, G4TC6F, G4TE4Y, G4TF5H, G4TG1P, G4TH10, G4TH7N, G4TJ81, G4TK3Y, G4TL3L, G4TM3A, G4TP5T, G4TR3V, G4TR8P, G4TT64, G4TU7F, G4TV0M, G4TW2K & G4TX4G. Product Code #: 03NSB12XT- Lot Code #'s:G4TV42, G4TY3Z.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL,CANADA,CHILE,CHINA,COLOMBIA,COSTA RICA, DOMINICAN REPUBLIC,ECUADOR, EL SALVADOR, GREECE, GUATEMALA, HONG KONG, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, NETHERLANDS ANTILLES, NICARAGUA, PANAMA SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA SPAIN, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES URUGUAY, and VENEZUELA.
  • Product Description
    ENDOPATH¿ XCEL" with OPTIVIEW" Technology trocar || Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U, G4RZ7L, G4T33Y & G4T58C. Product Code #: 03B11LPH- Lot #'s: G4RX8G, G4RZ3X & G4T03X. Product Code #: 03B11LT- Lot #'s: G4RH57, G4RH49, G4RJ9H, G4RK2U, G4RK90, G4RL5P, G4RM16, G4RM1F, G4RM7E,G4RN1E, G4RP3L, G4RT0T, G4RT9D, G4RV4M, G4RV4D, G4RW9Z, G4RX5R, G4RY23, G4RY7P, G4RZ6G, G4T093, G4T167, G4T22M, G4T27A, G4T27W, G4TC7V, G4TD1U, G4TE1P, G4TF0N, G4TF3J, G4TH07, G4TG6D, G4TH5L, G4TJ44, G4TK1J, G4TK6E, G4TL3A, G4TL95, G4TM49, G4TM88, G4TN2H, G4TN88, G4TP1R, G4TP4X, G4TP89,G4TR4X, || G4TT3K, G4TT97, G4TU8J, G4TV4W, G4TW1C, G4TX0C & G4TX8Z. Product Code #: 03B11LTH-Lot #'s: G4RW20, G4T03Y, G4T26Y, G4T49F, G4T73A, G4TX0R & G4TX9D. Product Code # 03B12LP-Lot #'s: G4RV5F, G4RY26, G4T27X, G4T55H & G4T75Y. Product Code #: 03B12LPH-Lot #'s: G4RW5T, G4RZ3Y, G4T03Z, G4T32C & G4T49G. Product Code #: 03B12LT-Lot #'s: F4PX6F, F4PZ4D, F4PZ22, F4PY9K, F4PY9E, F4PZ6F, F4PZ9Z, F4R01X, F4R039, F4R00M, F4R09W, F4R10Z, F4R15N, F4R18K, F4R18E, F4R234, F4R255, F4R278, F4R256, F4R35D, F4R34N, F4R34L, F4R369, F4R393, F4R40J, F4R44A, F4R458, G4R601, G4R71Y, G4R71Z, G4R80H, G4R77Z, G4R77Y, G4R860, G4R87V, G4R920, G4R915, G4R962, G4R97Z, || G4R84L, G4RA7D, G4RA8N, G4RC45, G4RC79, G4RC8D, G4RC98, G4RD2A, G4RC8E, G4RD24, G4RD4V, G4RE84, G4RG18, G4RG3T, G4RG83, G4RF0A, G4RH0C, G4RG31, G4RG32, G4RF8C, G4RJ08, G4RJ92, G4RJ9E, G4RK6L, G4RL02, G4RL1L, G4RL2E,G4RL8P, G4RL8Y, G4RM31, G4RM49, G4RN06, G4RN27, G4RN30, G4RN2K, G4RN5D, G4RN8F, G4RN7Z, G4RP1K, G4RR2N, G4RR3K, G4RT28, G4RT09, G4RT3G, G4RT3J,G4RU8H, G4RV1F, G4RV1G, G4RV89, G4RV8J, G4RW55, G4RW54, G4RX59, G4RZ15, G4RY7W, G4RY8V, G4RY8W, G4RZ29, G4RZ6W, G4RZ6V, G4RZ6H, G4RZ6U, G4T01U, G4T04J, G4T04H, G4T14X, G4T23R, G4T296, G4T34K, G4T36A, G4T34P, G4T41E, G4T44W, G4T46C, G4T45N, G4T50W, G4T529, G4T63Z, G4T66H, G4T64N, G4T66J, G4T750, G4T70Y, G4T711, || G4T73J, G4T78T, G4T81R, G4T78U, G4T83Y, G4T93A, G4T87T, G4T95J, G4T90T, G4T89V, G4T94W, G4T941, G4T940, G4T976, G4TA1E, G4TA5W, G4TA7D, G4TA5X, G4TA9H,G4TA96, G4TC3Y, G4TC4Y, G4TC4X, G4TC80, G4TD3W, G4TD3G, G4TF02, G4TD8Z, G4TD9Z, G4TF8Z, G4TG0W, G4TG31, G4TG4H, G4TG6X, G4TH16, G4TH5M, G4TH79, G4TJ2A, G4TJ6U, G4TJ5W, G4TJ8Y, G4TJ9W, G4TK2F, G4TK86, G4TK9H, G4TL5Z, G4TL7R, G4TL9N, || G4TM5T, G4TM3H, G4TM87, G4TP14, G4TR1F, G4TP7K, G4TR54, G4TR3A, G4TR7H, G4TR9M, G4TT0G, G4TT20, G4TT43, G4TT7R, G4TU1D, G4TU3J, G4TV22, G4TU89, G4TW0N, G4TV5V, G4TW3V, G4TW5U, G4TX16, G4TX2D, G4TX8R, G4TX7E & G4TY19. Product Code #: 03B12LTH- Lot #'s: G4RW31, G4RW2R, G4RZ48, G4T00F, G4T27C, G4T448, G4T56N, G4T549, G4T59L, G4T65G, G4T709, G4TE35, G4TF2E, G4TG03, G4TG73, G4TH21, G4TM00, || G4TT3F, G4TU3P &G4TX0T.; Product Code #: 03B12SRT- Lot #'s: G4RW52, G4RZ25, G4T05J, G4T465 & G4T76T. Product Code #: 04B12XT-Lot #'s: G4RU2U, G4RW8N, G4RV59, G4RW97, G4T19T, G4T79U, G4TA2A, G4TA7K, G4TD2C, G4TF0R, G4TJ1L, G4TM3X, G4TN8E, G4TR00, G4TT2W, G4TW4E, G4TW55 & G4TY7G. Product Code #'s: 03CB11LT-Lot #'s: G4RH8R, G4RK9Z, G4RL5R, G4RM8H, G4RN6Z, G4RT08, G4RV2F, G4RY0X, G4RZ5N, G4T12D, G4T20J, G4T31F, G4T444, G4T50E, G4TL5Y, G4TL8F, G4TU70 & G4TX6J. Product Code #: 03CB12LT-Lot Code #'s: F4R421, G4R93M, G4R989, G4RA4E, G4RA7Z, G4RA8M, G4RC4N, G4RD94, G4RG1F, G4RG4X, G4RG91, G4RH7X, G4RJ9A, G4RN3R, G4RR4T, G4RT8H, G4RU3C, G4RU6V, G4RV2U, G4RW9J, G4RY1R, G4RY6L, G4RZ68, G4T092, G4T14D, G4T229, G4T243, G4T26W, G4T31T, G4T32W, G4T37M, G4T37N, G4T410, G4T449, G4T45Z, G4T47R, G4T48G, G4T551, G4T71V, G4T74Z, G4T81K, G4T83U, G4T894, G4T92T, G4T98R, G4TA4Z, G4TA9X, G4TC2L, G4TC6L, G4TD1E, G4TD68, G4TE07, G4TE9W, G4TF2M, G4TG16, G4TG61, G4TG8P, G4TH58, G4TJ2G, G4TJ99, G4TK3H, G4TK1H, G4TL76, G4TM3D, G4TM5W, G4TN2E, G4TN81, G4TP0V, G4TP9D, G4TR4W, G4TR77, G4TU0L, G4TU86, G4TV4F, G4TV9F, G4TW9U & G4TX7P. Product Code #: 02D11LT- Lot Code #'s: G4RR2U, G4RR34, G4RT5N, G4RT47, G4RT53, G4RU05, G4RX11, G4RX7V, G4RZ28, G4RZ4M, G4T06C, G4T09H, G4T171, G4T18U, G4T28K, G4T38Y, G4T46L, G4T51N, G4T55T, G4T590, G4
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA