The Recall Desk

FDA (Devices) recall action 87157

Medtronic Neurosurgery recalled 3 products on 2021-02-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-02-24
Critical
0
Units
46,256

Why these products were recalled

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2021-02-24

    Medtronic Delta CSF Valves Recalled for Radiopaque Marking Visibility Issues

    Medtronic is recalling Delta CSF flow control valves because radiopaque markings may not be clearly visible under X-ray imaging.

    Product
    Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 2512
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2021-02-24

    Medtronic Recalls Cerebrospinal Fluid Valves Due to Radiopaque Marking Issues

    Medtronic Neurosurgery is recalling 22,528 units of STRATA II cerebrospinal fluid valves and shunts worldwide because radiopaque markings may vary in visibility under imaging.

    Product
    Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 2781
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2021-02-24

    Medtronic CSF-Flow Control Valves Recalled for Radiopaque Marking Visibility Issues

    Medtronic Neurosurgery is recalling 20,817 CSF-Flow Control Valves worldwide due to potential variation in radiopaque marking visibility under radiographic imaging.

    Product
    Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PE
    Category
    Distribution
    2 states