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SURGIPROS
Surgipros, LLC · Model 27618SP · UDI-DI 00810143901191
3
510(k) clearances
2,451
Adverse events (24 deaths)
13
Recalls
48
Facilities
Description
MANDRIN INSERTION CATHETER
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
| 2020-03-09 | Boston Scientific | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device |
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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.