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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93279

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 04, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Edwards Lifesciences, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.

Z-0409-2024
Recall number
Z-0409-2024
Initiated
October 04, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Edwards Lifesciences, LLC
Quantity
33,327 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Code information

AIQS6: UDI:00690103201079; Lot #s: 64858340 64933520 65027617; AIQS65: UDI:00690103200935; Lot # 64858715; AIQS6R: UDI:00690103201093/Lot #: 64858050 AIQS6R5: UDI:00690103200959/Lot #: 64835570 AIQS8: 00690103201086 UDI:/Lot # 64858150 64858716 64891667 64939370 65179001; AIQS85: UDI:00690103200942/Lot# 64858717 64892324 64892325 64892326 64892327 64904497 64904498 64918260 64918261 64918262 64918263 64918264 64918646 64918647 64918648 64918649 64918650 64918651 64918652 64988038 64988040 65067612; AIQS8R5: 00690103201178/UDI:; Lot # 64817843 64858645 64891410

Distribution pattern

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

device · product 2 of 6

Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Z-0410-2024
Recall number
Z-0410-2024
Initiated
October 04, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Edwards Lifesciences, LLC
Quantity
6,714 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Code information

AIQS6AZ: UDI: 00690103201109/ Lot # 64891675; AIQS6AZ5: UDI: 00690103200980/ Lot # 64858220, 64858220, 64858341, 64918655, 64933575, 64939369, 64964945, 64992113

Distribution pattern

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

device · product 3 of 6

FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Z-0411-2024
Recall number
Z-0411-2024
Initiated
October 04, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Edwards Lifesciences, LLC
Quantity
1417 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Code information

MHD8: UDI: 00690103194609/ Lot # 64874824, 64886991, 64897466, 64982736; MHD85: UDI: 00690103194616/ Lot # 64858315; MHD6R5: UDI:07460691949737/Lot # 65008717, 65008718; MHD8R: UDI: 07460691949829/Lot # 64892236, 65009105; MHD8R5: UDI:07460691949744/Lot # 64886927; MHD8S: UDI: 07460691949805/Lot # 65048926

Distribution pattern

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

device · product 4 of 6

FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.

Z-0412-2024
Recall number
Z-0412-2024
Initiated
October 04, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Edwards Lifesciences, LLC
Quantity
11,072 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Code information

MHD6AZ: UDI:00690103194722, Lot #: 64818047 64858313 64891437 64953982 MHD6AZ5: UDI: 00690103194746, Lot #: 64782419 64882668 64912054 64918246 64933574 64988043 65007223 65007224; MHD6C502: UDI: 00690103194760, Lot #: 64951410

Distribution pattern

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

device · product 5 of 6

TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm),PXMK2041: (3 cc), PXMK2321: (3cc)/48in (122cm), PXMK2331: x4 (3cc)/12 in (30cm), PXMK9146: x 2 (3cc), PXMK1876: x3(3cc), PXVK1099:(3cc)/62in (157cm), PXMK0102: x2 (3cc)/84in (213cm), PXMK2043:X3(3CC), T001657A: x2 (3cc)/210cm, T001658A: x2 (3cc)/180 cm, T001660A: X3 (3CC)/150CM, T001709A: X2 (3 cc)/210 cm,T001767A: (3cc)/60in (150cm), T321573A: (3cc)/66 in (165cm), T433803A (3cc)/200cm, T441T01C: (3cc)/225 cm, T494C00B: (3 cc)/180 cm,

Z-0413-2024
Recall number
Z-0413-2024
Initiated
October 04, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Edwards Lifesciences, LLC
Quantity
118,570 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Code information

PX212: UDI: 07460691950221/Lot # 65087613; PX260: UDI: 07460691950191/Lot #64817892, 64818036, 64818038, 64964776, 64964780; PX272: UDI: 07460691950207/Lot # 65067588 PX284: UDI: 07460691950214/Lot # 64980120, 64980121, 65008760, 65019888, 65019889, 65035079; PX2X2: UDI: 07460691950061/Lot # 64955114, 65012789, 65027868, 65170585; PX3X3284C:UDI: 07460691950269/Lot # 64906878, 65007202, 65019845; PX4X4: UDI: 07460691950665/Lot # 64807960, 64835551, 64858629; PX600F: UDI: 07460691945555/Lot # 64918553, 64951413, 65016989; PXMK1876: UDI: 07460691953826/Lot # 64817828, 64817963; PXMK1940: UDI: 07460691955981/Lot # 64858039; PXMK2024: UDI: 07460691958180/Lot # 64964690; PXMK2041: UDI: 07460691951464/Lot # 64933443, 64933444; PXMK2321: UDI: 07460691958784/Lot # 64912231; PXMK2331: UDI: 07460691959224/Lot # 64933498; PXMK9146: UDI: 07460691954427/Lot # 64992075; PXMK1876: UDI: 07460691953826/Lot # 64817963; PXVK1099: UDI: 07460691958753 /Lot # 65067568 PXMK0102: UDI: 00690103199932/ Lot # 65008741 PXMK2043: UDI: 07460691956230/ Lot # 64980031 T001657A: UDI: 07460691902046/Lot# 64686945, 64807966, 64918558, 64948620; T001658A :UDI: 07460691902053/Lot #65007203, 65036124; T001660A: UDI: 07460691902077/Lot # 64964732, 65019857; T001709A: UDI: 07460691947610/Lot# 64918560, 64964727, 65079483; T001767A: UDI: 07460691947306/Lot # 64891376, 64906871, 64980035, 64983290, 65035029; T321573A: UDI: 07460691910270/Lot# 64807975; T433803A: UDI: 07460691926714/Lot # 64722635; T441T01C: UDI: 07460691928848/Lot # 64835565; T494C00B:UDI: 07460691950313/Lot #64807969, 64918562;

Distribution pattern

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

device · product 6 of 6

TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in (160cm); PXVMP3X32: x3 (3cc)/VAMP 75in (190cm); PXVP0041: (3cc)/VAMP Plus 96in (244cm); PXVP0550: x3 (3cc)/VAMP Plus 91 in (231cm); PXVP1071: x3 (3cc)/VAMP Plus 87in (221cm); PXVP1087: x4(3cc)/VAMP Plus; PXVP2260: (3cc)/VAMP Plus 60in (150cm); PXVP2272: (3cc)/VAMP Plus 72in (180cm); PXVP2284: (3cc)/VAMP Plus 84in (210cm); PXVP2284AT3: (3cc)/VAMP Plus 84in (210cm); PXVP23X3: x3: (3cc)/VAMP Plus; PXVP23X3AT3: x3 (3cc)/VAMP Plus; PXVP2X2AT3: x2 (3cc)/VAMP Plus; PXVPL0111: (3cc)/VAMP Plus 84in (213cm); PXVMP160: 3cc/VAMP 60 in (150cm); PXVMP172: 3cc/VAMP 72in)180cm); PXVMP184:3cc/VAMP 84in (210cm); PXVMP260:3cc/VAMP 60in (150cm); PXVFL10017: (3cc)/VAMP Flex 83in (210cm); PXVP0034: (3cc)/VAMP Plus 87in (220cm); T001691A: (3cc)/VAMP Plus; T001691M: (3cc)/VAMP Plus (215cm); T001744M:(3cc)/VAMP 93in (236 cm); T100671M: x3(3cc)/VAMP Plus (215cm); T001760A :x2(3cc)/VAMP Plus; T001765A: (3cc)/60in (150cm); T005021M: (3cc)/VAMP Flex (195cm); T005089M: x2 (3cc)/VAMP Flex (195 cm) ; T005091M: x3(3cc)/VAMP Flex (195cm); T434501B: x2(3cc)/VAMP 88in (225cm); T440B26B: x2 (3cc)/VAMP 88in (225cm); T450545A: x3 (3cc)/VAMP 75in (190cm); T460241A: (3cc)/VAMP Plus 69in (175cm); T530219D: x2 (3cc)/VAMP Plus 65in (165cm)

Z-0414-2024
Recall number
Z-0414-2024
Initiated
October 04, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Edwards Lifesciences, LLC
Quantity
168,014 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Code information

PXAVMP:UDI: 00690103011494/Lot # 64817849; PXAVMP3: UDI:07460691950085/Lot # 64918575; PXVK0364:UDI:07460691954526/Lot # 64858007; PXVK0853: UDI: 07460691957671/Lot # 65060361; PXVK0996:UDI: 07460691955431/Lot # 64858275; PXVMP2X21:UDI: 07460691950115/Lot # 64992080; PXVMP2X22: UDI: 00690103016765/Lot # 64891427; PXVMP3X32:UDI: 0690103016802/Lot # 65008748; PXVP0041: UDI: 00690103197983/Lot # 64835537; PXVP0550:UDI: 07460691949911/Lot # 64818013, 64858077, 64891424, 64918588, 64985484; PXVP1071: UDI: 07460691955462/Lot # 64807998, 64807999; PXVP1087: UDI: 07460691957886/Lot # 65035078, 65079515; PXVP2260: UDI: 07460691950108/Lot # 64858071, 64858103, 64891419, 64906892; PXVP2272:UDI: 07460691950184/Lot # 64752261, 64906891, 65138017; PXVP2284: UDI: 07460691950177/Lot # 64818005, 64818008, 64818011, 64891421, 64933492, 64933493, 64964755, 64964759, 64964760, 64964761, 64998878, 65060446; PXVP2284AT3: UDI: 07460691950436/Lot # 64722680, 64858285, 64951434, 64980108, 64992088; PXVP23X3:UDI: 07460691950092/Lot # 64998879, 65060444; PXVP23X3AT3: UDI: 07460691950443/Lot # 64695848, 64779289, 64858072, 64858290, 64992092,65060447; PXVP2X2AT3: UDI:07460691950467/Lot # 64858075; PXVPL0111: UDI: 00690103200386/Lot # 64933462; PXVMP160: UDI:/Lot # 64779279, 64918578, 64933556, 64933559; PXVMP172: UDI:/Lot # 64835579; PXVMP184:UDI:/Lot # 64949045, 64983460, 65042811; PXVMP260:UDI:/Lot # 64629075, 64964750, 64980101; PXVFL10017:UDI:00690103210798/Lot # 64923241; PXVP0034:UDI:00690103197945/Lot # 64835538, 65019842; T001691A:UDI: 07460691947627/Lot # 64793360 64807977 64817834 64835567 64835568 65008739 65019862 65035054 65048943; T001744M:UDI: 07460691959507/Lot # 64526411, 64891383; T100671M:UDI: 07460691959491/Lot # 64912244; T001760A: UDI:07460691947566/ Lot # 65008764, 65019890, 65067580; T001765A: UDI:07460691947290/ Lot # 64891376, 64906871, 64980035, 64983290, 65035029; T005021M:UDI:07460691959538/ Lot # 64858230, 64923245; T005089M:UDI:07460691959545/Lot #64933442, 65060364 T005091M:UDI:07460691959552/Lot # 64807926 T434501B:UDI: 07460691956636/ Lot # 64817812 T440B26B:UDI:07460691949553/ Lot # 64817809, 64817936; T450545A:UDI: 07460691931572/ Lot # 65035081; T460241A: UDI:07460691949188/ Lot # 64933451; T530219D:UDI:07460691948259/ Lot # 65067546

Distribution pattern

US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam