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PowerCross
Covidien LP · Model AB18W060100150 · UDI-DI 00821684046883
LIT
Prescription
1
510(k) clearances
35,722
Adverse events (181 deaths)
32
Recalls
92
Facilities
Description
.018
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-03 | Boston Scientific Corporation | Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to |
| 2025-07-21 | SUMMA THERAPEUTICS, LLC | Potential for the balloon in the device to not meet burst specifications. |
| 2024-12-10 | ev3 Inc | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots. |
| 2024-09-19 | Covidien LP | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. |
| 2021-12-17 | Covidien Llc | The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remo |
| 2021-07-19 | Cordis Corporation | The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to |
| 2021-07-14 | Ostial Corporation | Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complicat |
| 2020-08-26 | ev3 Inc. | Labeling discrepancy for the Rated Burst Pressure (RBP) value. |
| 2020-01-08 | Cordis Corporation | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area. |
| 2019-10-11 | Nucryo Vascular Inc. | Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels. |
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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.