Class 1 Device Recall INTUA CRTP

• Date Initiated by Firm: June 03, 2021
• Date Posted: July 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2019-2021
• Recall Event ID: 88107
• PMA Number: P030005
• Product Classification: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
• Product: INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
• Code Information: 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, 605022, 605023, 605025, 605026, 605027, 605028, 605029, 605035, 605036, 605037, 605039, 605041, 605047, 605049, 605051, 605052, 605055, 605057, 605058, 605061, 605062, 605063, 605064, 605065, 605070, 605073, 605075, 605076, 605079, 605080, 605082, 605085, 605087, 605088, 605090, 605096, 605098, 605099, 605100, 605103, 605108, 605112, 605115, 605117, 605118, 605120, 605124, 605127, 605128, 605129, 605133, 605135, 605136, 605137, 605140, 605141, 605147, 605149, 605150, 605151, 605152, 605153, 605154, 605155, 605158, 605159, 605161, 605162, 605163, 605164, 605166, 605168, 605170, 605172, 605173, 605174, 605175, b) V273, Serial Numbers: 100001, 100002, 100006, 100007, 100013, 100014, 100015, 100017, 100019, 100030, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100042, 100044, 100045, 100046, 100047, 100048, 100049, 100054, 100056, 100057, 100058, 100060, 100062, 100066, 100067, 100069, 100071, 100072, 100076, 100083, 100084, 100086, 100087, 100088, 100089, 100090, 100091, 100093, 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118687, 118688.118690, 118691, 118692, 118693, 118694, 118695, 118696, 118700, 118701, 118702, 118703, 118705, 118706, 118707, 118708, 118709, 118711, 118713, 118714, 118717, 118718, 118719, 118721, 118722, 118724, 118725, 118727, 118728, 118729, 118731, 118732, 118733, 118734, 118735, 118736, 118737, 118739, 118741, 118742, 118743, 118745, 118751, 118755, 118756, 118758, 118759, 118760, 118761, 118763, 118765, 118766, 118767, 118768, 118769, 118771, 118772, 118773, 118774, 118775, 118776, 118777, 118778, 118779, 118781, 118782, 118785, 118786, 118788, 118789, 118790, 118792, 118794, 118795, 118797, 118798, 118799, 118800, 118804, 118807, 118810, 118812, 118813, 118815, 118816, 118820, 118821, 118822, 118823, 118824, 118825, 118826, 118827, 118828, 118829, 118830, 118835, 118836, 118837, 118838, 118839, 118840, 118842, 118846, 118848, 118849, 118850, 118854, 118856, 118859, 118860, 118861, 118863, 118864, 118865, 118867, 118869, 118870, 118871, 118873, 118874, 118875, 118876, 118877, 118879, 118880, 118882, 118883, 118884, 118885, 118886, 118887, 118888, 118891, 118894, 118895, 118896, 118897, 118898, 118899, 118900, 118901, 118902, 118903, 118907, 118908, 118909, 118910, 118912, 118914, 118918, 118919, 118920, 118921, 118922, 118923, 118924, 118928, 118929, 118933, 118935, 118936, 118937, 118938, 118939, 118942, 118944, 118945, 118946, 118947, 118949, 118950, 118951, 118954, 118955, 118957, 118958, 118959, 118961, 118962, 118967, 118968, 118972, 118974, 118977, 118978, 118979, 118980, 118981, 118982, 117901, 118894 c) W273, Serial Numbers: 100003, 100005, 100009, 100024, 100030, 100037, 100091, 100092, 100093, 100100, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100126, 100021, 100118, 100121, 100127
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N Bldg 3; Saint Paul MN 55112-5700
• For Additional Information Contact: United States Technical Services ; 800-227-3422
• Manufacturer 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
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NKE