The Recall Desk

FDA (Devices) recall action 77139

Sorin Group Italia SRL - CRF recalled 3 products on 2017-05-24

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
2017-05-24
Critical
0
Units
7,833

Why these products were recalled

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

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.

1–3 of 3

  • SevereFDA (Devices)··2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin is recalling specific defibrillator models because battery depletion may be undetectable. Physicians are being notified to check affected devices.

    Product
    OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac d
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin Group is recalling 37 implanted defibrillators because battery depletion may be undetectable. Physicians are being notified to monitor affected patients.

    Product
    INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac de
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-05-24

    Sorin Defibrillators Recalled for Undetectable Battery Depletion

    Sorin Group is recalling specific implantable defibrillators because battery depletion may be undetectable, posing a risk to patients.

    Product
    PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indic
    Category
    Distribution
    0 states