Medical device recalls: February 2021
The FDA posted 15 medical device recall records in February 2021, from 10 recall events by 10 companies. 8 are Class I, the most serious category.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Combat Medical Systems, LLC · 1 event, 5 records, 5 Class I
- Boston Scientific Corporation · 1 event, 2 records, 2 Class I
- CooperSurgical, Inc. · 1 event, 1 record
- Draegar Medical Systems, Inc. · 1 event, 1 record
- Heartware, Inc. · 1 event, 1 record, 1 Class I
- LumiraDx · 1 event, 1 record
- Mar-Med Co · 1 event, 1 record
- Phadia US Inc · 1 event, 1 record
FDA root cause
- Process control · 7
- Under Investigation by firm · 2
- Software design · 2
- Device Design · 2
- Process change control · 1
- Nonconforming Material/Component · 1
Class I recalls (8)
The most serious: a reasonable probability that using the device will cause serious health problems or death.
- Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. ↗Class IZ-1110-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- Z-1111-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- Z-1112-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- Z-1113-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- Z-1114-2021 · Combat Medical Systems, LLC · posted Feb 19, 2021 · Terminated
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
- EMBLEM S-ICD Model A209 ↗Class IZ-0950-2021 · Boston Scientific Corporation · posted Feb 5, 2021 · Terminated
Electrical overstress may lead to device malfunction.
- Z-0951-2021 · Boston Scientific Corporation · posted Feb 5, 2021 · Terminated
Electrical overstress may lead to device malfunction.
- Z-0946-2021 · Heartware, Inc. · posted Feb 4, 2021 · Open, Classified
Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall…
Class II recalls (7)
The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Z-1152-2021 · CooperSurgical, Inc. · posted Feb 26, 2021 · Terminated
The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.
- Z-1132-2021 · LumiraDx · posted Feb 17, 2021 · Terminated
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
- Z-1107-2021 · Phadia US Inc · posted Feb 11, 2021 · Terminated
Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
- Z-1104-2021 · Draegar Medical Systems, Inc. · posted Feb 10, 2021 · Open, Classified
The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be…
- Z-1098-2021 · Roche Diagnostics Operations, Inc. · posted Feb 8, 2021 · Terminated
May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower…
- Z-1084-2021 · Wahl Clipper Corp · posted Feb 5, 2021 · Terminated
The connection between the massager and heat element can overheat causing smoke or spark, which may pose a fire hazard
- Z-0945-2021 · Mar-Med Co · posted Feb 2, 2021 · Terminated
A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can…
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.