Medical inflation device recalled due to handle separation risk
Merit Medical Systems is recalling basixALPHA Inflation Devices due to a design flaw where the syringe handle can separate when withdrawn, affecting device functionality.
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: This FDA Class II device recall describes a structural design defect (handle separation) creating a risk of device malfunction during clinical use. Absent any reported injuries, this qualifies as a risk-of-harm product, meeting the criteria for High severity.
Plain-English summary
Merit Medical Systems, Inc. is recalling the basixALPHA Inflation Device 30 atm/bar 20 mL, which is used to inflate and deflate angioplasty balloons and measure balloon pressure during interventional procedures.
The devices are being recalled due to a design issue in which the inflation syringe handle can separate from the inflation device when the handle is withdrawn.
Approximately 7,211 devices have been distributed worldwide, including throughout the United States and multiple international locations. The affected products are identified by specific catalog numbers, UDI codes, and lot numbers provided in the recall notice.
The recalled product
- Product
- basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 7,211
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)
- Catalog Number: IN3130 UDI: 00884450440179
- 00884450510155
- Lot Numbers: H1862928
- H1896261
- H1923761
- H1929106
- H1939255
- H1966485
- H1978295
- H2068264
- H2073193
- H2073247
- H2077173
- Catalog Number: IN3152 UDI: 00884450511220 Lot Numbers: H1896262
- H1909581
- H1923762
- H1929107
- H1978299
- H2007415
- H2031599
Distribution
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