Reprocessed ultrasound catheters recalled over residual particulates on patient contacting surfaces
Medline is recalling 7,913 reprocessed ACUSON AcuNav ultrasound catheters because specific lots may carry small residual particulates on patient-contacting surfaces.
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 classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Reprocessed ACUSON AcuNav Ultrasound Catheters, used for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology and to visualize other devices in the heart during cardiac interventional percutaneous procedures, are being recalled. The devices carry Medline item numbers 10135910RH (for use on GE systems) and 10135936RH (for use on Siemens systems).
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If a device with residual particulates on patient-contacting surfaces is 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.
The recall covers 7,913 units distributed nationwide in the United States. The FDA has classified the recall as Class I.
Cardiac catheterisation and electrophysiology labs should identify affected lots by item number and UDI-DI and follow Medline's instructions for returning or quarantining stock.
The recalled product
- Product
- Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac…
- Manufacturer
- Medline Industries, LP
- Affected units
- 7,913
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)
- Item Number/UDI-DI 10135910RH (for use on GE Systems) 10197344026500
- 10135936RH (For use on Siemens Systems) 10197344026517
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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