Reprocessed AcuNav catheters recalled over residual material particles inside
Medline is recalling 511 reprocessed Siemens ACUSON AcuNav diagnostic ultrasound catheters because these lots may contain small particles of residual material.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters are being recalled by Medline Industries, LP, covering catheters for use on GE systems (10135910RH, 10043342RH) and on Siemens systems (10135936RH), among the catalog numbers listed in the enforcement record.
The record states these lots of reprocessed catheters may contain small particles of residual material. It states that 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. The record notes this is an expansion of recall Z-2610/2614-2025.
The record lists 511 units, with UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected stock and follow Medline's instructions.
The recalled product
- Product
- Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
- Manufacturer
- Medline Industries, LP
- Affected units
- 511
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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