BD Recanalization System May Overheat or Break During Use
Bard Peripheral Vascular is recalling BD Recanalization Systems due to a manufacturing defect that may allow continuous operation without required safety warnings, increasing risk of device overheating or breaking during patient treatment.
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: FDA Class II with no reported injuries or illnesses. However, the malfunction creates genuine risk during patient treatment (overheating or breaking of catheter equipment). Per the rubric, this is a 'risk-of-harm product where injury has not yet been reported,' warranting score 3 (High).
Plain-English summary
Bard Peripheral Vascular Inc is recalling 403 BD Recanalization Systems (REF: BDRECANSYSTEM) distributed across the United States and Puerto Rico. The device is used in vascular recanalization procedures.
Some units were manufactured in a mode that allows the system to continuously run without the typical 30-second pauses and required 4-minute warning and 5-minute restart messages. These messages are designed to alert users when the maximum 10-minute catheter use time has been exceeded.
The malfunction increases the risk of device overheating or breaking during use. Affected units are identified by serial numbers BSX000001 through BSX000443 (with gaps in the sequence) with UDI-DI 00801741202421.
Healthcare facilities and providers should immediately cease use of recalled units and contact Bard Peripheral Vascular Inc for instructions regarding the recall. Do not reuse affected devices.
The recalled product
- Product
- BD Recanalization System, REF: BDRECANSYSTEM
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Vascular
- Affected units
- 403
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)
- UDI-DI: 00801741202421. Serial Numbers: BSX000001
- BSX000002
- BSX000003
- BSX000004
- BSX000005
- BSX000006
- BSX000007
- BSX000008
- BSX000009
- BSX000010
- BSX000011
- BSX000012
- BSX000013
- BSX000014
- BSX000015
- BSX000016
- BSX000017
- BSX000018
- BSX000019
- BSX000020
Distribution
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