Devices

Device Recall Heartstring II Proximal Seal aortic cutter

Model / Serial
HSK-2038, HSK-2043. All lots are affected by this recall.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed to 274 consignees. 15 are international distributors. 259 hospitals. The product is fully distributed to the following countries: USA, Belgium, CAnada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Israel, Italy, Lebanon, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, and Swizerland. 3 VAs received product: 13000 Bruce B Downs Blvd, Tampla, FL, 800 Hospital Dr., columbia, MO, and 921 NE 13th st., Oklahoma City, OK.
Product Description
Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
Manufacturer
Guidant Cardiac Surgery
1 Event
- Recall of Device Recall Heartstring II Proximal Seal aortic cutter

Manufacturer

Guidant Cardiac Surgery

Manufacturer Address
Guidant Cardiac Surgery, 3200 Lakeside Dr, Santa Clara CA 95054-2807
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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