Bard Caliber Inflation Device Recalled for Pressure Limitations
Perouse Medical is recalling Bard Caliber inflation devices that may fail to reach required pressure, potentially delaying angioplasty procedures.
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 high-risk medical device where a functional defect (inability to reach required pressure) poses a risk of harm through incomplete inflation or procedure delay, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Perouse Medical is recalling 24,821 units of the Bard Caliber (CL3030) Inflation Device. This medical device is intended for use during cardiovascular angioplasty procedures to create, maintain, and monitor pressure in balloon catheters.
The recall was initiated because the device may be unable to raise pressure above 10 atm during the inflation phase. This limitation may result in incomplete inflation of the balloon catheter or a delay in the procedure. The affected units are identified by lot numbers beginning with 1403, 1404, 1405, 1406, or 1407.
The devices were distributed nationwide in the United States, specifically in the states of Arizona and Colorado. Healthcare facilities and users should stop using the affected devices and contact Perouse Medical for further instructions.
The recalled product
- Product
- Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
- Manufacturer
- PEROUSE MEDICAL
- Category
- Medical Device — Cardiovascular
- Affected units
- 24,821
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 (5)
- All lot numbers beginning with Numbers: 1403
- 1404
- 1405
- 1406
- 1407
Distribution
Part of a larger recall action
This product is one of 2 recalled by PEROUSE MEDICAL 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.
See all 2 products in this recall →Related recalls
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