Terumo Recalls Titan Stabilizer Attachments Due to Suction Tubing Clip Breakage Risk
Terumo CVS is voluntarily recalling specific lots of Titan Stabilizer Attachments because the Suction Tubing Clip may break and fall into the surgical site.
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 risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is voluntarily recalling certain lots of Titan Stabilizer Attachments and Titan 360 Stabilizer Attachments. The recall involves 1,463 units of the devices.
The recall is being issued because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is intended for convenience and is not required for the device to operate, there is a potential for broken fragments of the clip to fall into the surgical site during use.
The affected products were distributed domestically and to foreign consignees, but not to government agencies or Canada. Specific lot numbers for the Titan Stabilizer Attachment include 052R, and for the Titan 360 Stabilizer Attachment include 020R, 024R, 026R, 029R, 030R, 034R, 035R, 037R, 040, and 048R. Healthcare providers should stop using these specific lots and contact the manufacturer for instructions on how to return or dispose of the devices.
The recalled product
- Product
- Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 1,463
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)
- Catalog Number: 401-231
- Product Description: Titan" Stabilizer Attachment
- Lot Number: 052R Catalog Number 401-231u
- Product Description TitanTM 360 Stabilizer Attachment
- Lot Number: 020R
- 024R
- 026R
- 029R
- 030R
- 034R
- 035R
- 037R
- 040
- 048R
Distribution
Distribution scope not specified by the agency.
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