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U.S. Department of Health and Human Services

Class 1 Device Recall Imager II

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 Class 1 Device Recall Imager IIsee related information
Date Initiated by FirmAugust 24, 2026
Date PostedSeptember 23, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3214-2026
Recall Event ID 99687
510(K)NumberK121694 
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
ProductImager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101 IMAGER II/5/BERN/65/038 BX5; M001314141 IMAGER II/5/H1/100/038 BX5; M001314151 IMAGER II/5/H1/100/035 BX 5; M001314301 IMAGER II/5/SIM1/65/038 BX5; M001314321 IMAGER II/5/SIM1/100/038 BX5; M001314341 IMAGER II/5/SIM2/100/038 BX5; M001314351 IMAGER II/5/SIM2/100/035 BX 5; M001314361 IMAGER II/5/SIM3/100/038 BX5; M001314521 IMAGER II/5/CHGB/65/038 BX5; M001314581 IMAGER II/5/CONTRA 2/65/038 BX5; M001314621 IMAGER II/5/C1/65/038 BX5; M001314661 00AGER II/5/C2/65/038 BX5; M001314671 IMAGER II/5/C2/65/035 BX 5; M001314761 IMAGER II/5/MIK/65/038 BX5; M001314771 IMAGER II/5/MIK/65/035 BX 5; M001314821 IMAGER II/5/SHK1.0/65/038 BX5; M001314861 IMAGER II/5/RC2/65/038 BX5; M001314881 IMAGER II/5/RDC/65/038 BX5
Code Information M001314001 UDI-DI 08714729354826 Batches 74B2500089 74C2600048 74E2500888 74G2500942 74H2500390 74K2400624 74K2500754 74L2400920 M001314011 UDI-DI 08714729354833 Batches 74B2500937 74F2500509 74L2400427 74L2400913 74L2500679 74M2400314 M001314021 UDI-DI 08714729354840 Batches 74A2500370 74C2500582 74E2500889 74E2600070 74G2500421 74H2500875 74K2400982 74K2500755 74L2500841 M001314031 UDI-DI 08714729354857 Batches 74B2501237 74D2600727 74F2500968 74M2400317 M001314041 UDI-DI 08714729354864 Batches 74A2500996 74B2600070 74D2501155 74D2600456 74G2500951 74K2401116 M001314051 UDI-DI 08714729354871 Batches 74A2500586 74A2500997 74B2500090 74B2500711 74B2500940 74B2501238 74B2600079 74B2600310 74B2600390 74B2600412 74B2600573 74C2501047 74C2600348 74C2600430 74C2600531 74D2500124 74D2500424 74D2501156 74D2600455 74D2600857 74D2601116 74E2500982 74E2501194 74F2500511 74F2500599 74F2500768 74G2500422 74G2500759 74G2501153 74G2501349 74H2500392 74H2500659 74H2500665 74H2501042 74J2500318 74J2500552 74K2401330 74K2500164 74K2500756 74K2500917 74L2400720 74L2500033 74L2500680 74M2400072 74M2400304 74M2400318 74M2500245 M001314061 UDI-DI 08714729354888 Batches 74A2500044 74A2500587 74A2600261 74A2600415 74B2500091 74B2500488 74B2600080 74B2600895 74C2500053 74C2500583 74C2600350 74D2500125 74D2500426 74D2600575 74E2500201 74E2500293 74E2500981 74E2501195 74F2500969 74G2500778 74G2501350 74H2501041 74J2500085 74K2400625 74K2500759 74L2400041 74L2400411 74L2400418 74L2401248 74L2401259 74L2500681 74L2500831 74L2500939 74M2400303 74M2400305 M001314081 UDI-DI 08714729354901 Batches 74A2500375 74A2600681 74B2500489 74B2600042 74B2600328 74B2600329 74C2500584 74D2500427 74E2500294 74E2501196 74E2600412 74E2600413 74F2500722 74G2500910 74G2500943 74G2501351 74H2500234 74H2501035 74K2401069 74L2400419 74L2400687 74L2500359 74L2500682 74M2400306 M001314101 UDI-DI 08714729354925 Batches 74A2500376 74A2500461 74A2600324 74A2600417 74A2600680 74B2600572 74B2600590 74B2600840 74C2500021 74C2500046 74C2500585 74C2600043 74C2600044 74C2600532 74C2600810 74D2500604 74D2500682 74D2600039 74D2600050 74D2600578 74E2500295 74E2501197 74E2600071 74E2600193 74E2600194 74E2600870 74F2500120 74F2500767 74F2500970 74F2600059 74F2600328 74G2500476 74G2500944 74H2500383 74J2500170 74J2500547 74K2400361 74K2401070 74K2401317 74K2500165 74K2501039 74L2400939 74L2401250 74L2500367 74M2400075 74M2500092 74M2500571 M001314141 UDI-DI 08714729354963 Batches 74A2501084 74A2600685 74B2600078 74B2600575 74D2600457 74G2500945 74K2401113 74M2500705 M001314151 UDI-DI 08714729354970 Batches 74C2500767 74E2600505 74F2500121 74F2500967 74L2401249 M001314301 UDI-DI 08714729355120 Batches 74A2500462 74A2600059 74B2500490 74C2500768 74C2600046 74C2600733 74E2500296 74F2500971 74F2600062 74F2600329 74G2500190 74H2500223 74J2500080 74K2400362 74L2500032 74M2500572 M001314321 UDI-DI 08714729355144 Batches 74A2500588 74B2500491 74B2501240 74B2600539 74C2500769 74D2600571 74F2500122 74G2500191 74G2500947 74H2500235 74L2401251 74M2500706 M001314341 UDI-DI 08714729355168 Batches 74A2500589 74B2500492 74B2600591 74C2500770 74D2500683 74D2600572 74E2500297 74F2500123 74G2501345 74H2500236 74J2500083 74K2401321 74K2500758 74L2400689 74M2400065 74M2500084 74M2500576 74M2500708 M001314351 UDI-DI 08714729355175 Batches 74A2500590 74A2600416 74B2500708 74C2500771 74D2500684 74E2500298 74E2600507 74F2500124 74G2500192 74G2501346 74H2500237 74K2401322 74M2400066 74M2400783 74M2500242 M001314361 UDI-DI 08714729355182 Batches 74F2500125 74M2500709 M001314521 UDI-DI 08714729355342 Batches 74E2500646 M001314581 UDI-DI 08714729355403 Batches 74A2500463 74A2500988 74A2600331 74A2600683 74A2600684 74B2500709 74C2500772 74C2600045 74C2600702 74D2500685 74E2500647 74E2600072 74F2500126 74F2600060 74G2500193 74H2500384 74J2500305 74K2400615 74K2400616 74K2401117 74K2501040 74L2400424 74L2400721 74L2400938 74L2401290 74L2500029 74M2400734 74M2500093 M001314621 UDI-DI 08714729355441 Batches 74A2500990 74A2501085 74A2501087 74D2500686 74E2500301 74E2500648 74F2500127 74H2500225 74J2500306 74K2400617 74K2501041 74L2400722 74L2400915 74L2401253 74L2500370 74M2400078 M001314661 UDI-DI 08714729355489 Batches 74A2500993 74A2501311 74A2600061 74A2600682 74B2500493 74B2500710 74C2500047 74C2500773 74C2600533 74D2500687 74D2500881 74D2600579 74E2500649 74F2500128 74F2500503 74G2500194 74H2500226 74H2500385 74J2500086 74J2500307 74K2400618 74K2500166 74K2501042 74L2400916 74L2401254 74L2500021 74L2500371 74L2500683 74M2400067 74M2400079 74M2500573 M001314671 UDI-DI 08714729355496 Batches 74A2500111 74A2501312 74A2600058 74C2500048 74C2501039 74C2600530 74D2500882 74D2600577 74E2500650 74F2500504 74G2500195 74H2500386 74J2500308 74K2400619 74K2401114 74K2501165 74M2400068 74M2500574 M001314761 UDI-DI 08714729355588 Batches 74A2501313 74C2500774 74E2500651 74E2500882 74F2600061 74G2500224 74K2500753 M001314771 UDI-DI 08714729355595 Batches 74A2501314 74C2500049 74C2600703 74D2500038 74D2500883 74E2500883 74E2600508 74E2600869 74F2500505 74F2600058 74G2500333 74H2500873 74J2500316 74J2500549 74L2400426 74L2500689 74M2400069 M001314821 UDI-DI 08714729355649 Batches 74A2600702 74B2500082 74B2600311 74C2500050 74C2501041 74F2500506 74K2500163 74L2400937 M001314861 UDI-DI 08714729355687 Batches 74C2500051 74L2400936 74M2500086 M001314881 UDI-DI 08714729355700 Batches 74E2500884 74G2500226 74G2500334 74J2500311 74K2400620 74L2500022
FEI Number 3002095335
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactClara Johnson
763-494-1700
Manufacturer Reason
for Recall		Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
FDA Determined
Cause 2		Process control
ActionFirm began notifying customers on August 24, 2026. Customers were instructed to immediately stop further use or distribution and segregate affected product. Customers should continue to follow the standard of care when monitoring patients treated with the product. Customers were advised to utilize both inner and outer packaging UPN codes when searching for affected product. Customers were provided with instructions to return product.
Quantity in Commerce262,686
DistributionWorldwide - US Nationwide and territories of Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Barbados, Belgium, Brazil, Brunei Dar-es-S, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Rep N Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad, Tobago, Tunisia, T¿rkiye, UAE, Ukraine, United Kingdom, USA, W. Bank Gaza Strip, Yemen.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = DQO
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