Reprocessed Electrophysiology Catheters Recalled for Residual Particles
Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device with serious potential harms explicitly described: granulomatous reactions, thrombus formation, and risk of cerebral, pulmonary, or deep vein embolism. Class I classification by the FDA agency itself mandates a minimum score of 4 per the rubric.
Plain-English summary
Medline Industries, LP is recalling specific lots of reprocessed electrophysiology and ultrasound catheters, including St. Jude Medical Response Diagnostic Electrophysiology Catheter models (Item no. 401206RH and 401305RH, Lot EP250203). The devices may contain small particles of residual material on patient-contacting surfaces.
If these catheters with residual particles are used in clinical procedures, there is a potential risk of an inflammatory response or systemic infection. If particulate material dislodges during use and contacts circulating blood or the heart, it may produce a granulomatous reaction or blood clot formation, which may lead to cerebral embolism, pulmonary embolism, or deep vein thrombosis.
The devices have been distributed nationwide in Texas. Patients and healthcare providers who have received or used these catheters should contact their physician or Medline Industries regarding return or replacement. Healthcare facilities should review their inventory and discontinue use of affected lot numbers.
The recalled product
- Product
- 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.
- Manufacturer
- Medline Industries, LP
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot EP250203 Item no. 401206RH - UDI-DI 10197344043767
- Item no. 401305RH - UDI-DI 10197344043637.
Distribution
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