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PROWLER
Medos International Sàrl · Model 606-2310M · UDI-DI 10886704028673
KRA
Prescription
2
510(k) clearances
9,056
Adverse events (362 deaths)
96
Recalls
148
Facilities
Description
PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 20 cm 135 cm MAX Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1 mm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-18 | Angiodynamics, Inc. | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. |
| 2023-11-06 | Merit Medical Systems, Inc. | The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| 2022-06-30 | Micro Therapeutics, Inc. | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| 2022-06-30 | Micro Therapeutics, Inc. | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| 2020-11-03 | Boston Scientific Corporation | This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certa |
| 2017-11-09 | Vascular Insights, LLC | Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction |
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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.