Sequent Medical Recalls VIA 27 Microcatheter Due to Re-sheathing Defect
Sequent Medical is recalling 618 units of the VIA 27 Microcatheter because the device may not adequately re-sheath interventional devices as designed.
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 is classified as FDA Class II. The hazard involves a functional defect in a medical device used in vascular procedures, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Sequent Medical Inc is recalling 618 units of the VIA 27 Microcatheter (Part No. FG27-154-01, Model No. VIA-27-154-01). The recall was initiated because the microcatheter may not adequately re-sheath the interventional device into the catheter as designed.
The VIA 27 Microcatheter is intended for the introduction of non-liquid interventional devices, such as stents and flow diverters, and for the infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculature. The device is inserted into the body through a small puncture in the skin and into a blood vessel.
The affected units were distributed worldwide, including in the United States (NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, WV) and internationally to the Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark. Healthcare providers and patients should contact Sequent Medical for further instructions regarding the recall.
The recalled product
- Product
- VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro…
- Manufacturer
- Sequent Medical Inc
- Hazard
- Affected units
- 618
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 (14)
- 16031101
- 16042901
- 16051201
- 15102107
- 15102701
- 15111201
- 15112003
- 16010403
- 16011409
- 16012901
- 16040801
- 16041501
- 16052603
- 16061701
Distribution
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