Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401...
Reason for Recall / Hazard
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Product Description & Identification
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Affected Products
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 99122 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767; Item no. 401305RH - UDI-DI 10197344043637. |
| Postal code | 60093-2753 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 3 |
| Reason for recall | Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260515 |
| Initial firm notification | Letter |
| Center classification date | 20260702 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass I
- DistributionUS Nationwide distribution in the state of TX.