Biorep Atrial Lift System Recalled for Support Arm Detachment
Biorep Technologies is recalling the Joseph Lamelas Atrial Lift System because the support arm may detach from the blade body during use.
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, and the defect involves a surgical instrument used in cardiac surgery where failure could lead to patient harm, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Biorep Technologies is recalling the Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. This product is a single surgical instrument used for retraction of the atrial wall tissue in cardiac surgery. The recall involves 80 boxes, containing a total of 480 units.
The recall was initiated because the support arm, which is attached to the body of the blade with an adhesive, is detaching while attempting to engage the visor component. This defect could compromise the function of the surgical instrument during cardiac procedures.
The affected units were distributed in the United States to a distributor in Minnesota. The specific lot numbers involved are 166934413 (expiration date 2016/12/10) and 166903414 (expiration date 2017/02/03). Healthcare facilities and distributors should stop using these units and contact Biorep Technologies for instructions on return or replacement.
The recalled product
- Product
- Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
- Manufacturer
- Biorep Technologies
- Hazard
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 (2)
- Lot numbers: 166934413 (expires 2016/12/10)
- and 166903414 (expires 2017/02/03).
Distribution
Distributed in 1 state:
Related recalls
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- HighBiomet Recalls A.L.P.S. Medium Bone Plate Forceps Due to Assembly Error
FDA (Devices) · 2015-07-22
- HighMedical X-ray display system support arm may lower unexpectedly
FDA (Devices) · 2024-08-14
- ModerateAesculap Recalls UNITRAC Pneumatic Retraction Arms Due to Safety Instructions
FDA (Devices) · 2013-10-30
- SevereVilla Sistemi Medicali Recalls Apollo EZ X-Ray Systems Due to Footrest Detachment
FDA (Devices) · 2017-03-15
- SevereApollo DRF X-ray Systems Recalled Due to Footrest Detachment Hazard
FDA (Devices) · 2017-03-15
- HighLuminos dRF Max X-ray Display Support Arm May Unintentionally Lower
FDA (Devices) · 2024-08-14