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ABSORB GT1
ABBOTT VASCULAR INC. · Model 1235300-08 · UDI-DI 08717648213014
PNY
Prescription
0
510(k) clearances
929
Adverse events (110 deaths)
1
Recalls
3
Facilities
Description
Absorb GT1 Bioresorbable Vascular Scaffold System 3.00 mm x 8 mm / Rapid-Exchange
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-04-26 | Abbott Vascular | Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myoca |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.