Baylis ProTrack Microcatheter Recalled for Circumferential Shaft Cracks
Baylis Medical Corp is recalling 433 ProTrack Microcatheters nationwide due to circumferential cracks along the shaft.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (cracks) that poses a risk of harm during use, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baylis Medical Corp is recalling 433 units of the ProTrack Microcatheter, models CIC38-145 and CIC35-145. These sterile, single-use devices are intended for use as standard infusion wires or exchange guides in cardiovascular procedures. The recall is due to the potential presence of circumferential defects, specifically cracks, along the catheter shaft.
The affected products were distributed nationwide. The recall includes units with specific lot codes, including CIFA161013, CIFA131113, and others listed in the agency record. The source text does not report any specific illnesses or injuries associated with this defect.
Healthcare providers and consumers should stop using the affected ProTrack Microcatheters immediately. Users should check their inventory for the specific model numbers and lot codes listed in the recall notice. For further information or to arrange a return, contact Baylis Medical Corp.
The recalled product
- Product
- ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
- Manufacturer
- Baylis Medical Corp *
- Affected units
- 433
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 (20)
- CIFA161013
- CIFA131113
- CIFA271113
- CIFA311213
- CIFA210214
- CIFA070314
- CIFA270314
- CIFA070514
- CIFA210514
- CIFA100614
- CIFA240614
- CIFB100714
- CIFA100714
- CIFA180814
- CIFA080914
- CIFA241014
- CIFA221014
- CIFA050115
- CIFA210115
- CIFA060215
Distribution
Distributed nationwide across the United States.
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