CLASS II Device recall · Reported 14 Apr 2021 · FDA Enforcement Report
Consist of a distal connection mechanism recalled
Terumo Cardiovascular Systems is recalling Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or, distributed nationwide in the US. The recall was initiated on 2 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1367-2021
- FDA event ID
- 87504
- Recalling firm
- Terumo Cardiovascular Systems, Elkton, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Mar 2021
- FDA classified
- 6 Apr 2021
- Reported
- 14 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 2 Mar 2021 | Recall initiated by company | |
| 6 Apr 2021 | Classified by FDA | +35 days |
| 14 Apr 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
Where it was distributed
US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
Nationwide MarylandNew HampshireNew JerseyNevadaPennsylvaniaTennesseeWisconsin
Questions about this recall
Why was it recalled?
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
Which lots are affected?
GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, T00412.
Where was it sold?
US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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