Z-2019-2021Class I

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

Name: Z-2019-2021 INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Creator: Boston Scientific Corporation
Published: 2021-06-03
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-06-03 / Open, Classified / root cause: design

FDA source

Boston Scientific Corporation began a recall of INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 on 2021-06-03. FDA classified it as Class I and gives the reason as "The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2019-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-06-03
Posted: 2021-07-13
Recalling firm: Boston Scientific Corporation
Product: INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Product code: NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Reason for recall: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued an advisory communication on June 3, 2021 by letter to the implanting/following physicians and clinics regarding the potential device behavior. The notice included a letter to the patients to be disseminated to the patients implanted with the device at the discretion of the physician. BSC also made the patient letter available on their advisory page, found on our product performance website @ https://www.bostonscientific.com/en-US/pprc/product-advisories.html
Quantity in commerce: 1707 units
Distribution: Worldwide distribution.
Product codes and lots: a) V272, Serial Numbers: 100002, 100014, 100017, 100021, 100028, 100037, 100048, 100052, 100053, 100054, 100065, 100067, 100068, 100075, 100077, 100080, 100092, 100093, 100096, 100097, 100098, 100099, 100101, 100104, 100106, 100107, 100108, 100114, 100116, 100118, 100119, 100120, 100124, 100127, 100136, 100152, 100153, 100155, 100159, 100161, 100162, 100165, 100168, 100170, 100171, 100173, 100175, 100176, 100179, 100194, 100195, 100199, 100201, 100202, 100203, 100205, 100206, 100211, 100212, 100216, 100218, 100219, 100221, 100224, 100226, 100227, 100228, 100230, 100232, 100233, 100237, 100238, 100240, 100241, 100242, 100245, 100247, 100249, 100250, 100253, 100256, 100257, 100258, 100261, 100266, 100270, 100272, 100276, 100277, 100280, 100281, 100287, 100289, 100290, 604977, 604982, 604984, 604986, 604987, 604988, 604991, 604992, 604998, 604999, 605002, 605003, 605004, 605005, 605006, 605007, 605009, 605010, 605011, 605013, 605014, 605015, 605017, 605020, 605021, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2019-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2015-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2016-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2017-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2018-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2019-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12
Z-2020-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-12

Product code NKE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)