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Gateway®
BOSTON SCIENTIFIC CORPORATION · Model M0032072220400 · UDI-DI 08714729795384
NJE
Prescription
0
510(k) clearances
7,840
Adverse events (537 deaths)
7
Recalls
17
Facilities
Description
PTA Balloon Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-05 | Stryker Neurovascular | Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported |
| 2014-10-22 | Stryker Neurovascular | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. |
| 2013-06-24 | Stryker Neurovascular | The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Mode |
| 2011-03-21 | Codman & Shurtleff, Inc. | Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length, when in fact the product is 28mm in length. |
| 2010-08-25 | Boston Scientific Corporation | Products may not meet radial force specifications. |
| 2010-03-01 | Boston Scientific Corporation | The product may contain manufacturing aids (mandrels) which should not be present in the final product. If the mandrel remains in place, the catheter cannot be loaded over the requ |
| 2009-05-08 | Boston Scientific Corporation | Mislabeling-- Product was placed in a carton, which has printed on it the name of another product. A correct product label was placed on the carton. |
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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.