PRCClass 3
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA adverse event reports and recall history for drug-coated peripheral transluminal angioplasty catheter (product code PRC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 518
- Deaths
- 8
- Injuries
- 410
- Malfunctions
- 100
Reports per year
217
1118
1019
1620
2421
2722
3123
6624
27325
5826
Source: FDA adverse event reports by year received, 2017–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- Open, ClassifiedPackaging process control
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
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