Urgent Field Safety Notice For Shockwave C2 Aero Coronary Ivl Catheter By Shockwave Medical
Summary Shockwave Medical is recalling the Shockwave C2 AERO Coronary IVL Catheter, a medical device used in heart procedures. The recall was classified as Class I, the most serious category. The affected devices were distributed in Germany and the European Union.
- Recalling firm
- Urgent Field Safety Notice for Shockwave C2 AERO Coronary IVL Catheter by Shockwave Medical , Download_VeroeffentlichtAm
- Product
- s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Shockwave C2 AERO Coronary IVL Catheter by Shockwave Medical 2026
- Reason
- assessment Field corrective actions Urgent Field Safety Notice for Shockwave C2 AERO Coronary IVL Catheter by Shockwave Medical 2026
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-05-05
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/f17f51bc-d7b8-443d-8e4b-ba7725a52fbe