Device product
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH
Z-1320-2026
Product summary
- Event
- Event 98277
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 311
- Official record key
device-enforcement:Z-1320-2026
Official wording
Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Code information: 81105RH UDI-DI 10197344133253 Lot EP250618; 81172RH UDI-DI 10197344133284 Lot EP250618; 81202RH UDI-DI 10197344133307 Lot EP250618; 81483RH UDI-DI 10197344133444 Lot EP250618; 81102RH UDI-DI (case) 20197344133236¿ (ea) 10197344133239 Lot EP250618; 81104RH UDI-DI 10197344133246 Lot EP250618; 81174RH UDI-DI 10197344133291 Lot EP250618; 81531RH UDI-DI 10197344133512 Lot EP250618; 81532RH UDI-DI 10197344133529 Lot EP250618; 81107RH UDI-DI 10197344133260 Lot EP250618; 81402RH UDI-DI 10197344133352 Lot EP250618; 81404RH UDI-DI 10197344133376 Lot EP250618; 81405RH UDI-DI 10197344133383 Lot EP250618; 81474RH UDI-DI 10197344133437 Lot EP250618; 81473RH UDI-DI 10197344133420 Lot EP250618
Distribution pattern: Distribution US nationwide.
Derived failure modes
-
Unknown
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025